Dawson Mueller G10435Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00827002104358), received between Mar 16, 2017 and Jun 16, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 16, 2026Material Split, Cut or Torn

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS DIFFICULT TO INSERT DURING A LIVER ABSCESS DRAINAGE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER LIKE COOK PIGTAIL DRAINAGE CATHETER. THE DEVICE WAS RECEIVED 09JUN2026, REVEALING A TEAR IN THE CATHETER TIP AND A SEPARATED SUTURE. THUS, PROMPTING THIS REPORT. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25522776 ↗
• MalfunctionMar 17, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED. UPON INSERTION OF THE CATHETER, NO FLUID COULD BE ASPIRATED DUE TO A LEAK IDENTIFIED AT THE CATHETER HUB. THIS LEAK PREVENTED THE RETURN OF SECRETION THROUGH THE CATHETER. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE.AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620620 ↗
• InjuryNov 12, 2025Material Separation; Material Separation

  IT WAS REPORTED THAT THE "END PART OF THE PIGTAIL" FROM AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER "BROKE OFF". THE DEVICE WAS PLACED IN AN UNKNOWN PATIENT AS A CHEST TUBE. IT WAS NOTED THAT THERE WAS LIMITED "WEAR AND TEAR" ON THE CATHETER. THE CATHETER REQUIRED REMOVAL AND REPLACEMENT WITH AN UNKNOWN NEW DEVICE. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23533729 ↗
• MalfunctionJun 9, 2025Break; Break

  IT WAS REPORTED THAT THE HUB OF AN ULTRATHANE DAWON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER BROKE. AT THE BEGINNING OF A NEPHROSTOMY CATHETER EXCHANGE PROCEDURE, A FRACTURE IN THE MAC-LOC HUB WAS OBSERVED. THE DEVICE HUB EXHIBITED COMPLETE SEPARATION INTO FRAGMENTS. FOR THIS REASON, THE DEVICE WAS NOT USED. A PHOTO PROVIDED BY THE CUSTOMER SHOWS THE MAC-LOC WAS FRACTURED ABOVE THE HUB CAP. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22166511 ↗
• MalfunctionOct 30, 2024Obstruction of Flow; Migration; Obstruction of Flow; Migration

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER MIGRATED FOLLOWING PLACEMENT IN A 52-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS PREVIOUSLY TREATED WITH FLUIDS FOR LIVER ABSCESS AT ANOTHER HOSPITAL. ON (B)(6) 2024 AT 13:00, SHE CAME IN WITH ABDOMINAL DISTENSION AND FEVER AND WAS ADMITTED TO THE HOSPITAL. A DRAINAGE CATHETER WAS THEN PLACED UNDER ULTRASOUND TO DRAIN THE LIVER ABSCESS. AT 16:00, THE NURSE NOTICED THAT THE CATHETER WAS NOT DRAINING THE PUS AND NOTIFIED THE PHYSICIAN TO EXAMINE THE PATIENT'S CONDITION. UPON EXAMINATION, REDNESS OF SKIN, AND SLIGHT INCREASE IN TEMPERATURE AT THE INSERTION SITE WERE NOTED. A BLOCKAGE IN THE CATHETER WAS SUSPECTED. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE ULTRASOUND ROOM AND THE DRAINAGE CATHETER WAS REPOSITIONED UNDER ULTRASOUND GUIDANCE. BY 20:00, APPROXIMATELY 10 ML OF PUS WAS DRAINED. THE SKIN REDNESS PERSISTED BUT THE SKIN TEMPERATURE WAS NORMAL. THE DOCTOR ADMINISTERED SYMPTOMATIC ANTI-INFLAMMATORY TREATMENT. A COMBINATION OF DRUG/MECHANICAL INTERVENTION INCLUDED SKIN STERILIZATION WITH IODOPHOR, LIDOCAINE SURFACE INFILTRATION AND INTRAVENOUS ADMINISTRATION OF 100ML SALINE WITH 1.5

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20570888 ↗
• MalfunctionJan 25, 2024Fluid/Blood Leak; Fluid/Blood Leak

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2024. BEFORE USING THE DEVICE ON THE PATIENT, THE CATHETER WAS TESTED BY THE DOCTOR. A LEAK WAS FOUND IN THE DISTAL THREAD OF THE CONNECTION. ANOTHER DRAIN WAS IMMEDIATELY REQUESTED TO COMPLETE THE PROCEDURE. THE COMPLAINT DEVICE DID NOT MAKE PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18581672 ↗
• MalfunctionApr 1, 2022Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE FOR ABSCESS DRAINAGE. AFTER THE DEVICE WAS IN PLACE, AIR WAS NOTED TO BE LEAKING FROM THE MAC-LOC LEVER. THE DEVICE WAS REMOVED AND REPLACED TO COMPLETE THE PROCEDURE. THERE WAS NO DAMAGE NOTED TO THE DEVICE. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13981074 ↗
• MalfunctionMar 10, 2022Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  IT WAS REPORTED THAT AN ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER LEAKED WHILE IMPLANTED IN AN UNKNOWN PATIENT. FOLLOWING PLACEMENTS ON (B)(6) 2022, IT WAS NOTED THAT DRAINAGE FROM THE PATIENT'S DAWSON MUELLER CATHETER WAS LOW. AT AN UNKNOWN TIME IN (B)(6), A LEAK WAS DISCOVERED AT THE ENTRY SITE OF THE CATHETER INTO THE SKIN. THE PATIENT WAS REPORTEDLY IN PAIN WHEN FLOW THROUGH THE CATHETER WAS COMPROMISED. FLUSHING THE CATHETER RESOLVED THE LEAK, HOWEVER NO VISIBLE STONES WERE FOUND. A NEPHROSTOGRAM PERFORMED ON (B)(6) 2022 REVEALED THAT THE TUBE WAS PERFECTLY PLACED. THE CURRENT TUBE IS STILL IN USE BY THE PATIENT, WHO WILL UNDERGO A CATHETER EXCHANGE IN MARCH. NO HARM TO THE PATIENT HAS CURRENTLY BEEN REPORTED. ADDITIONAL INFORMATION REGARDING EVENT DETAILS HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: Pain

  MAUDE report 13724965 ↗
• MalfunctionDec 8, 2021Difficult to Remove; Difficult to Remove

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12960716 ↗
• MalfunctionMay 21, 2021Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11866533 ↗
• MalfunctionAug 16, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  NO NEW EVENT DESCRIPTION INFORMATION TO REPORT AT THIS TIME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8902360 ↗
• MalfunctionSep 26, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD) PROCEDURE, THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HAD NO AIR PRESSURE WITHIN THE CATHETER AND THE AIR WAS LEAKING FROM THE CATHETER HUB DURING IN THE PROCESS OF DRAINING. AS A RESULT, THE CATHETER WAS EXCHANGED FOR ANOTHER. THE PATIENT IS REPORTEDLY "HEALTHY" FOLLOWING THIS EVENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.  ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7912098 ↗
• InjuryJul 11, 2018Material Separation; Material Separation

  IT WAS REPORTED THAT A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS PLACED IN THE PATIENT'S KIDNEY AND WHILE THE PATIENT WAS AT HOME AFTERWARDS, THE HUB CAME OFF OF THE DRAIN WITHIN ONE DAY OF PLACEMENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A PHOTO FROM THE CUSTOMER SHOWS WHAT APPEARS TO BE A HUB SEPARATION. NO ADVERSE EFFECT TO THE PATIENT. THE DEVICE WAS REMOVED AND REPLACED WITH NO ADDITIONAL INTERVENTIONS NEEDED.

  Patient problems: No Code Available

  MAUDE report 7680512 ↗
• MalfunctionMar 5, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PRE-USE INSPECTION OF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER, A HAIR WAS DISCOVERED WITHIN THE PRIMARY PACKAGE OF THE DEVICE. THE DEVICE WAS NOT USED ON A PATIENT; ACCORDINGLY, NO PATIENT ADVERSE EVENTS RESULTED FROM THE PRODUCT ISSUE. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7315312 ↗
• MalfunctionJan 18, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE HUB OFF THE ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER WAS "LEAKING ONCE WE INSERTED AND BECAUSE OF THE LEAK, THE DEVICE HAD TO BE REPLACED." THERE WAS NO REPORT OF AN ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE CUSTOMER, BUT NONE HAS YET BEEN PROVIDED. THE DEVICE WAS RECEIVED FOR EVALUATION; HOWEVER, AS OF THE DATE OF THIS REPORT, THE INVESTIGATION IS STILL PENDING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7204674 ↗
• InjuryNov 10, 2017Fluid/Blood Leak

  IT WAS REPORTED THAT A PATIENT OF UNKNOWN AGE AND GENDER HAD A BILIARY STENT IN PLACE AND UNDERWENT A PROCEDURE TO HAVE A BILIARY DRAIN PLACED ABOVE THE BILIARY STENT AS A BACKUP. TWO HOURS AFTER THE PROCEDURE WHILE IN RECOVERY IT WAS NOTED TO BE LEAKING AT THE HUB. THE PATIENT WAS TAKEN BACK TO HAVE THE DRAIN REPLACED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADDITIONAL ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 7018361 ↗
• MalfunctionNov 9, 2017Air Leak; Detachment Of Device Component

  THE DRAIN WAS INSERTED INTO THE PATIENT AND THE PHYSICIAN ASPIRATED. HOWEVER, THE PHYSICIAN NOTICED AIR IN THE SYRINGE INSTEAD OF FLUID. THE PHYSICIAN THEN REATTEMPTED TO SECURE THE LOCK AND FORM THE PIGTAIL. CONTRAST WAS INJECTED, BUT AIR REMAINED IN THE SYRINGE. THE DRAIN WAS REMOVED AND CLAMPED HALFWAY DOWN THE CATHETER, BUT IT ASPIRATED AIR AGAIN. UPON INSPECTION OF THE TUBE, A SLIGHT PULL WAS USED AND THE HUB SEPARATED FROM THE CATHETER. THE DRAIN WAS REPLACED WITH A NEW DEVICE, AND THERE WERE NO INJURIES OR ADDITIONAL PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7015960 ↗
• InjuryNov 9, 2017Disconnection

  IT WAS REPORTED THAT THE HUB DISCONNECTED FROM THE CATHETER, REQUIRING AN ADDITIONAL PROCEDURE TO REPLACE THE DEVICE. ASIDE FROM THIS REPLACEMENT PROCEDURE, THERE WERE NO FURTHER INJURIES.

  Patient problems: No Code Available

  MAUDE report 7012915 ↗
• MalfunctionAug 22, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTS THAT A PATIENT UNDERWENT PLACEMENT OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER FOR PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE (PTBD). THE CUSTOMER REPORTS THAT "IN THE PROCESS OF DRAINING AFTER THE PTBD PROCEDURE, THERE WAS NO AIR PRESSURE WITHIN THE CATHETER AND THE AIR WAS LEAKING FROM THE CATHETER HUB." NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL EVENT AND PATIENT INFORMATION WAS REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ANY ADDITIONAL INFORMATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811612 ↗
• MalfunctionAug 9, 2017Leak/Splash; Leak/Splash

  CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER. IMPLANTATION OF THE DEVICE WAS SUCCESSFUL. THE CUSTOMER STATED "THE DRAIN WENT IN FINE, BUT WHEN THEY WENT TO INJECT CONTRAST IT WAS LEAKING." THE CUSTOMER IDENTIFIED A CRACK IN THE DEVICE HUB. THE CATHETER WAS EXCHANGED INTRA-OPERATIVELY FOR A NEW DAWSON-MUELLER. THERE ARE NO REPORTED ADVERSE PATIENT CONSEQUENCES RELATED TO THIS EVENT. THE DEVICE IS REPORTEDLY AVAILABLE FOR EVALUATION; HOWEVER IT HAS NOT BEEN RECEIVED BY THE MANUFACTURER AS OF THE DATE OF THIS REPORT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6777355 ↗
• MalfunctionMar 16, 2017Leak/Splash; Leak/Splash

  INTERNATIONAL CUSTOMER REPORTED THAT THE HUB OF A ULTRATHANE DAWSON-MUELLER MAC-LOC LOCKING LOOP MULTIPURPOSE DRAINAGE CATHETER HAD A LEAK. EVENT WAS NOTED WHILE THE USER WAS ASPIRATING BILE USING A SYRINGE. THE DEVICE WAS EXPLANTED AND RETURNED FOR EVALUATION. IT IS NOT KNOWN IF THE PATIENT REQUIRED A REPLACEMENT DEVICE. THE CUSTOMER REPORTS THERE WAS NO PATIENT IMPACT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6409739 ↗